Associate Director, Regulatory Affairs - Drug-Device Combination Products F/H (CDI)

Job Title: Associate Director, Regulatory Affairs - Drug-Device Combination Products

Reference: AMB-ATM25092D Industry: Medical Technologies Contract Type: Permanent Region: Auvergne-Rhône-Alpes City: Pont-de-Claix (Grenoble, France)

Our client is a global leader in the field of medical devices (pre-filled syringes, injection and safety systems, etc.), used by the world's largest pharmaceutical and biotechnology companies. Recognized for the quality and innovative nature of its products, the company stands out through its deep understanding of pharmaceutical processes and strong customer orientation.

Position

This strategic role is part of an ongoing transformation aimed at increasing the impact of the regulatory function: evolving from a support function to a proactive business partner, able to propose solutions, collaborate cross-functionally both internally and with clients, and influence effectively in a complex matrix environment.

Reporting to the WW Regulatory Affairs Sr. Director, you will manage a team of around twenty collaborators (including 4 direct reports) split between France and the USA. You will foster a shared vision, structure the team, support the development of regulatory expertise and client orientation. You will set the direction and establish a framework that combines maximization of collective performance with individual motivation.

Your main responsibilities will include:

• Driving regulatory strategy for combination products (drug-device), supporting clients and the geographic expansion of existing products.
• Managing, supporting, and developing RA teams within the scope of Life Cycle Management & Customer Support.
• Building a proactive and transformation-oriented culture by simplifying processes, highlighting regulatory activities as business enablers, and strengthening operational efficiency.
• Leading interactions and negotiations with regulatory authorities (FDA, EMA, and others), ensuring compliance of submitted dossiers.
• Supporting client projects related to regulatory submissions and product extensions.
• Defining and tracking relevant performance indicators, ensuring collective performance, managing underperformance, and maintaining direction with resilience and exemplary leadership.
• Representing the RA function to internal and external stakeholders, acting as a driver of change within an international matrix environment.

Profile

An inspiring, motivating leader, focused on talent development and continuous improvement, your background has enabled you to acquire the following skills:

• Advanced scientific degree (PhD, PharmD, or equivalent) with significant experience in Regulatory Affairs in the pharmaceutical, medical device, and ideally combination product (drug-device) industries.
• Solid managerial experience, including leading multidisciplinary and international teams, structuring activities, defining and monitoring performance indicators, and implementing corrective actions.
• Proven experience in interactions with regulatory authorities and managing international submissions, with strong knowledge of U.S. regulations (FDA), GxP, and Quality System Regulation.
• Ability to thrive in a complex matrix environment, with strong communication skills in both French and English, as well as influence, assertiveness, and leadership.
• Strong client and business orientation, with the ability to support change, give meaning, and engage teams in a transformational dynamic.

Conditions & Mobility

Permanent position, based in Pont-de-Claix (near Grenoble, France), with an expected on-site presence 4 days/week.

International travel (United States): approx. 4 times/year.

Attractive package including base salary, bonus, and group benefits.

We are an equal opportunities employer and welcome applications from all qualified candidates. We are committed to creating a diverse and inclusive workplace and encourage applications from underrepresented groups.